510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+8K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+8K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+8K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+8K202780SectumNeauvia North America20211—
+8K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+8K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K193486Epic 980Biolase, Inc.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192224BTL-899Btl20198—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K183247dpl FacewareLed Technologies, Inc.201910—
+8K183118dpl SpotLiteLed Technologies, Inc.201922—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+8K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+8K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+8K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K171262TempSureCynosure, Inc.201716—
+8K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+8K172004truSculptCutera, Inc.20173—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+8K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161981Olive PlusAma Network, Inc.20160—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+8K161661Thermi RF AccessoriesThermi20163—